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CompletedNCT07644871Updated Jun 12, 2026

A 4-week Study Investigating Two Targeted Brightening Serum (A and B) Versus 4% Hydroquinone in Women With Mild to Severe Full-face Hyperpigmentation

An interventional study of Facial Cleanser and Facial Moisturizer in Hyperpigmentation, Melasma and Dark Spots, sponsored by Revision Skincare. Completed at 1 site in United States. Open to female participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Revision Skincare · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Aug 2025, registered Jun 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
Female
01

Study summary

This a short four-week pilot study to measure the efficacy and tolerance of two brightening serums (cosmetics) versus 4% hydroquinone. The study was conducted in two sites across the USA, one in PA and in one in CA. The goal was to run the pilot study in the summer to understand the role of these two potential brightening serums in helping the appearance of skin tone evenness.

Read the detailed description

This is a four-week multi-center, single-blind, randomized, split-face, controlled pilot study conducted to assess the efficacy and tolerance of two pigment correction formulations (Brightening Serum A and Brightening Serum B) compared to 4% Hydroquinone split face when used over the course of 4 weeks by healthy females with clinically determined mild to severe facial hyperpigmentation, including melasma on the global face. Subjects will be randomized into 2 cells which will receive the following split face treatments:

  • Cell 1: Brightening Serum A versus 4% Hydroquinone
  • Cell 2: Brightening Serum B versus 4% Hydroquinone It was hypothesized that the Brightening Serum A and B will produce statistically significant improvements at post-baseline timepoints when compared with baseline, and comparable improvements versus the standard of care 4% Hydroquinone across the primary endpoint, secondary and tertiary endpoints. Additionally, the Sponsor's test materials will be well tolerated by subjects, with no statistically significant increases in scores for tolerability/safety parameters, specifically erythema and dryness, at any study timepoint when compared with baseline scores. Furthermore, the Sponsor's test materials will be well perceived by subjects according to analyses of self-assessment questionnaires, with a statistically significant proportion of favorable responses compared to unfavorable responses and/or a statistically significant improvement in subject response values when compared with baseline.
02

Conditions studied

  • Hyperpigmentation
  • Melasma
  • Dark Spots
03

In context

Hyperpigmentation

127 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.

This study's enrollment of 18 is below the median of 32 across 113 interventional studies indexed under Hyperpigmentation.

Browse Hyperpigmentation studies →

Lead sponsor

Revision Skincare is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.
  • Having Fitzpatrick skin type I-VI (refer to Appendix I: Fitzpatrick Skin Type)
  • Age 20 to 60 years.
  • Subjects with self-perceived hyperpigmented facial skin
  • Having mild to severe (score of 3-9 according to a modified Griffiths scale,2 where 0 = none, 1 to 3 = mild, 4 to 6 = moderate, 7 to 9 = severe) full-face hyperpigmentation, including melasma. Hyperpigmentation and melasma must present at equal severity and size on each facial side.
  • Willing to maintain visit 1/baseline condition of eyebrows and eyelashes (do not noticeably change brow/lash appearance) during the study.
  • Willing to provide written and able to read, speak, write, and understand English.
  • Willing to sign a photography release.
  • Having not had any facial treatments in the past 6 months and are willing to withhold all facial treatments during the course of the study including facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin (Botox®), injectable filler treatments, intense pulsed light (IPL), acid treatments, tightening treatments, facial plastic surgery, or any other treatment administered by a physician or skin care professional designed to improve the appearance or firmness of facial skin. Waxing and threading are allowed but not facial laser hair removal.

Exclusion criteria

Exclusion Criteria:

  • Having been diagnosed with known allergies to skin care products.
  • Having a known reactivity to tranexamic acid, niacinamide, sunflower seed, coconut, rosemary, barley, goji, sandalwood, licorice root, radish root, beeswax, yeast, ascorbic acid, tetrahexyldecyl ascorbate, and/or any of the ingredients in the study products.
  • Breastfeeding, pregnant, or planning to become pregnant during the study according to subject self-report.
  • Having a history of skin cancer within the past 5 years.
  • Currently taking oral or topical prescription medications for melasma such as Triluma, compounded hydroquinone, retinoids, and tranexamic acid.
  • Currently using oral or topical prescription medications for acne such as doxycycline, minocycline, clindamycin, bactrim, tetracycline, erythromycin, vibramycin, azelaic acid, benzoyl peroxide, Dapsone, or sodium sulfacetamide.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    Brightening Serum A

    The brightening serum A is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamoyl Dipeptide-23, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.

    Other: Facial Cleanser · Other: Facial Moisturizer · Other: Sunscreen SPF 55

  • Active comparator
    Brightening Serum B

    The brightening serum B is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamic acid, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.

    Other: Facial Cleanser · Other: Facial Moisturizer · Other: Sunscreen SPF 55

  • Other
    4% Hydroquinone

    This topical 4% hydroquinone cream was applied split-face to side randomized for application.

    Other: Facial Cleanser · Other: Facial Moisturizer · Other: Sunscreen SPF 55

Interventions

  • OtherFacial Cleanser

    Gentle Foaming Cleanser to wash the face two times a day (am/pm)

  • OtherFacial Moisturizer

    Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).

  • OtherSunscreen SPF 55

    Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step

06

What researchers measure

Primary outcomes

  1. Measurement of Clinical Efficacy Parameters by Clinical Grader

    Clinical grading efficacy parameters measured by blinded clinical grader including skin tone evenness, hyperpigmentation on the global face, and overall appearance. Grading was performed on a 10-point Griffith's scale, where 0 = best possible outcome 9= severe skin condition. A decrease in score/ value indicates an improvement.

    Time frame: Baseline, week 2, week 4

Secondary outcomes

  1. Measurement of Global Melasma Severity Assessment Score (GMSA)

    The expert grader (Board-Certified Dermatologist) will evaluate the right and left facial side using a Global Melasma Severity Assessment (GMSA) according to the following numerical definitions. Half-point scores may be used as necessary to more accurately describe the skin condition. 0 = clear 1. = mild 2. = moderate 3. = severe

    Time frame: baseline and weeks 2 and 4

Other outcomes

  1. Measurement of facial Melasma

    The MASI score is a clinical tool used to assess the severity of melasma, a hyperpigmentation disorder, in terms of both area and darkness. It quantifies the extent and intensity of melasma in four facial regions: the forehead (F), right malar region (MR), left malar region (ML), and chin (C), corresponding to 30%, 30%, 30%, and 10% of the total face, respectively. A decrease in score indicates improvement

    Time frame: Baseline, week 2 and week 4

  2. Incidence of Treatment- Emergent Adverse Events

    Local cutaneous tolerability was evaluated by assessing the signs and symptoms of the following objective and subjective irritation parameters globally on each subject's face. Objective irritation (clinically graded): erythema, edema, and dryness. Subjective irritation (assessed by subjects): burning, stinging, and itching. Local cutaneous tolerability was evaluated by assessing objective (erythema, edema, and dryness) and subjective (burning, stinging, and itching) irritation parameters globally on each subject's face using a 4-point scale (0 = none to 3 = severe). A decrease in value indicates an improvement.

    Time frame: Baseline, week 2, and week 4

07

Study locations

1 site
  • Revision Skincare
    Irving, Texas 75063, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07644871
Lead sponsor
Revision Skincare
Responsible party
Sponsor
First posted
Jun 12, 2026
Start date
Aug 11, 2025
Primary completion
Nov 12, 2025
Completion
Nov 12, 2025
Last update
Jun 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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